BEUDAMED
    FDA Adverse Event Injury Summary report: N

    .5MM CORTEX SCREW SELF-TAPPING 26MM

    MDR report key: 6077998 · Received November 3, 2016

    Report

    Report Number
    2520274-2016-15215
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 17, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: HRS. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 DUE TO FOUR (4) BROKEN SCREWS AND INFECTION. ON (B)(6) 2016, THE PATIENT WAS ORIGINALLY IMPLANTED WITH THREE (3) PLATES (INCLUDING A LONG PLATE) AND TWELVE (12) SCREWS DUE TO A LEFT TIBIAL PILON FRACTURE. ON AN UNKNOWN DATE IT WAS DISCOVERED THAT THERE WERE FOUR (4) BROKEN DISTAL SCREWS IN THE LONG PLATE. ON (B)(6) 2016, THE THREE (3) PLATES AND ALL SCREWS WERE REMOVED. THE SURGERY WAS SUCCESSFULLY COMPLETED; ALL FRAGMENTS WERE EASILY REMOVED AND THERE WAS NO SURGICAL DELAY. THE PATIENT WAS BEING TREATED WITH INTRAVENOUS ANTIBIOTICS AND ANTIBIOTIC CEMENT BEADS. ON (B)(6) 2016, BONE GRAFT FROM THE TIBIA WAS COLLECTED WITH THE REAMER IRRIGATOR ASPIRATOR (RIA) AND IMPLANTED IN THE DISTAL TIBIA; AND A DIFFERENT, LONGER PLATE AND SCREWS WERE IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS 11 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727103 .5MM CORTEX SCREW SELF-TAPPING 26MM SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention